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Randomized Controlled Trial of E-Counseling for Hypertension: REACH.
Nolan, RP, Feldman, R, Dawes, M, Kaczorowski, J, Lynn, H, Barr, SI, MacPhail, C, Thomas, S, Goodman, J, Eysenbach, G, et al
Circulation. Cardiovascular quality and outcomes. 2018;(7):e004420
Abstract
BACKGROUND The efficacy of internet-based interventions to improve hypertension management is not established. We evaluated the therapeutic benefit of e-counseling by adapting best evidence guidelines for behavioral counseling. METHODS AND RESULTS This multicenter double-blind randomized controlled trial included assessments at baseline, 4 months, and 12 months. Participants were 35 to 74 years of age and diagnosed with hypertension: systolic/diastolic blood pressure (BP) 130 to 180/85 to 110 mm Hg. BP was assessed by automated office measurement. E-Counseling used multimedia and interactive tools to increase motivation and skill for self-care (exercise, diet, medication adherence, and smoking cessation). Control used self-care education. Frequency of contact by our e-platform was equal for both trial arms. Primary end points were change at 4 and 12 months in systolic BP, diastolic BP, pulse pressure, total lipoprotein cholesterol, low-density lipoprotein cholesterol, total lipoprotein cholesterol/high-density lipoprotein cholesterol ratio, non-high-density lipoprotein cholesterol, and Framingham 10-year cardiovascular risk index. Intention-to-treat analysis used generalized linear models adjusted for baseline measures, sex, and medications. Among 264 participants, mean age was 57.6 years (SE, 0.6), 58% were women, with 83% on antihypertensive medications. At 12 months, e-counseling versus control evoked greater reduction in systolic BP (-10.1 mm Hg [95% confidence interval (CI), -12.5, -7.6] versus -6.0 mm Hg [95% CI, -8.5, -3.5]; P=0.02); pulse pressure (-5.2 mm Hg [95% CI, -6.9, -3.5] versus -2.7 mm Hg [95% CI, -4.5, -0.9]; P=0.04), and Framingham risk index (-1.9% [95% CI, -3.3, -0.5] versus -0.02% [95% CI, -1.2, 1.7]; P=0.02), respectively. Among males in e-counseling versus control, 12-month end points included lower diastolic BP (P=0.01), non-high-density lipoprotein cholesterol (P=0.04), total lipoprotein cholesterol (P=0.03), and a trend for total lipoprotein cholesterol/high-density lipoprotein cholesterol ratio (P=0.07). CONCLUSIONS To our knowledge, this is the first double-blind randomized trial of e-counseling for hypertension. Added benefit for medical therapy was achieved by combining available technology with a clinically organized protocol of motivational and cognitive-behavioral counseling. CLINICAL TRIAL REGISTRATION https://www.clinicaltrials.gov; Unique identifier: NCT01541540.
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A Randomized Controlled Trial of an Intensive Nutrition Intervention Versus Standard Nutrition Care to Avoid Excess Weight Gain After Kidney Transplantation: The INTENT Trial.
Henggeler, CK, Plank, LD, Ryan, KJ, Gilchrist, EL, Casas, JM, Lloyd, LE, Mash, LE, McLellan, SL, Robb, JM, Collins, MG
Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation. 2018;(5):340-351
Abstract
OBJECTIVE Excessive weight gain is common after kidney transplantation and increases cardiovascular risk. The aim of this randomized controlled trial was to determine whether an intensive nutrition and exercise intervention delivered alongside routine post-transplant care would reduce post-transplant weight gain. DESIGN Single-blind, randomized controlled trial. SUBJECTS AND SETTING Adult kidney transplant recipients at a regional transplant center were recruited during routine outpatient clinic visits in the first month after transplant. Patients with a body mass index >40 kg/m2 or <18.5 kg/m2, severe malnutrition, or ongoing medical complications were excluded. INTERVENTION Participants were randomized to intensive nutrition intervention (individualized nutrition and exercise counselling; 12 dietitian visits; 3 exercise physiologist visits over 12 months) or to standard nutrition care (guideline based; 4 dietitian visits). MAIN OUTCOME MEASURES The primary outcome was weight at 6 months after transplant adjusted for baseline weight, obesity, and gender, analyzed using analysis of covariance. The secondary outcomes included body composition, biochemistry, quality of life, and physical function. RESULTS Thirty-seven participants were randomized to the intensive intervention (n = 19) or to standard care (n = 18); one intensive group participant withdrew before baseline. Weight increased between baseline, 6 and 12 months (78.0 ± 13.7 [standard deviation], 79.6 ± 13.0 kg, 81.6 ± 12.9 kg; mean change 4.6% P < .001) but at 6 months did not differ significantly between the groups: 77.0 ± 12.4 kg (intensive); 82.2 ± 13.4 kg (standard); difference in adjusted means 0.4 kg (95% confidence interval: -2.2 to 3.0 kg); analysis of covariance P = .7. No between-group differences in secondary outcomes were observed. Across the whole cohort, total body protein and physical function (gait speed, sit to stand, grip strength, physical activity, and quality of life [all but 2 domains]) improved. However, adverse changes were seen for total body fat, HbA1c, and fasting glucose across the cohort. CONCLUSIONS Kidney transplant recipients in the first year after transplant did not benefit from an intensive nutrition intervention compared with standard nutrition care, although weight gain was relatively modest in both groups.
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A randomized controlled trial of lorcaserin and lifestyle counselling for weight loss maintenance: changes in emotion- and stress-related eating, food cravings and appetite.
Chao, AM, Wadden, TA, Pearl, RL, Alamuddin, N, Leonard, SM, Bakizada, ZM, Pinkasavage, E, Gruber, KA, Walsh, OA, Berkowitz, RI, et al
Clinical obesity. 2018;(6):383-390
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Abstract
Anti-obesity medication may help people maintain diet-induced reductions in appetite. The present exploratory analysis assessed the effects of lorcaserin on changes at 24 weeks post-randomization in emotion- and stress-related eating, food cravings and other measures of appetite (i.e. binge eating, cognitive restraint, disinhibition, hunger, preoccupation with eating and fullness). The parent study investigated the efficacy of combined lorcaserin and behavioural treatment in facilitating weight loss maintenance (WLM) in 137 adults (mean age = 46.1 years, 86.1% female, 68.6% black) who had lost ≥5% of initial weight during a 14-week, low-calorie diet (LCD) run-in. Participants were randomly assigned to lorcaserin or placebo and were provided with group WLM counselling sessions. Emotion- and stress-related eating, food cravings and appetite were measured at the start of the LCD (week -14), randomization (0) and week 24. From randomization, lorcaserin-treated participants had significantly greater improvements in emotion- and stress-related eating compared to placebo-treated participants (P = 0.04). However, groups did not differ significantly after randomization in changes in the frequency of food cravings, binge eating or other measures of appetite (Ps > 0.05). Compared to placebo, lorcaserin may improve emotion- and stress-related eating.
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Text messaging approach improves weight loss in patients with nonalcoholic fatty liver disease: A randomized study.
Axley, P, Kodali, S, Kuo, YF, Ravi, S, Seay, T, Parikh, NM, Singal, AK
Liver international : official journal of the International Association for the Study of the Liver. 2018;(5):924-931
Abstract
BACKGROUND & AIMS Nonalcoholic fatty liver disease (NAFLD) is emerging as the most common liver disease. The only effective treatment is 7%-10% weight loss. Mobile technology is increasingly used in weight management. This study was performed to evaluate the effects of text messaging intervention on weight loss in patients with NAFLD. METHODS Thirty well-defined NAFLD patients (mean age 52 years, 67% females, mean BMI 38) were randomized 1:1 to control group: counselling on healthy diet and exercise, or intervention group: text messages in addition to healthy life style counselling. NAFLD text messaging program sent weekly messages for 22 weeks on healthy life style education. Primary outcome was change in weight. Secondary outcomes were changes in liver enzymes and lipid profile. RESULTS Intervention group lost an average of 6.9 lbs. (P = .03) compared to gain of 1.8 lbs. in the control group (P = .45). Intervention group also showed a decrease in ALT level (-12.5 IU/L, P = .035) and improvement in serum triglycerides (-28 mg/dL, P = .048). There were no changes in the control group on serum ALT level (-6.1 IU/L, P = .46) and on serum triglycerides (-20.3 mg/dL P = .27). Using one-way analysis of variance, change in outcomes in intervention group compared to control group was significant for weight (P = .02) and BMI (P = .02). CONCLUSIONS Text messaging on healthy life style is associated with reduction in weight in NAFLD patients. Larger studies are suggested to examine benefits on liver histology, and assess long-term impact of this approach in patients with NAFLD.
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Effects of behavioral counseling on cardiometabolic biomarkers: A longitudinal analysis of the Japanese national database.
Ikeda, N, Nishi, N, Miyachi, M
Preventive medicine. 2018;:116-121
Abstract
In Japan, health insurers are obliged to conduct Specific Health Checkup (SHC) for middle-aged and elderly persons. High-risk persons are referred to Specific Health Guidance (SHG) to receive behavioral counseling based on individual action plans including targets for modification of daily energy balance through diet and physical activity. Using individual-level observational data, we examined the effects of diet and physical activity counseling on cardiometabolic biomarkers across the country. Subjects were 363,440 high-risk persons aged 40-64 who participated in intensive support in SHG for ≥3 months between April 2008 and March 2012. We considered participants as receiving counseling on diet alone, physical activity alone, combined, or neither if they had targets for diet only, physical activity only, both, or neither, respectively. Biomarkers included body mass index, waist circumference, systolic and diastolic blood pressure, high-density lipoprotein cholesterol, and hemoglobin A1c. Under the difference-in-differences approach, we used multivariable linear regression on repeated measures of biomarkers at SHCs before and after SHG and estimated the effects of each counseling type as an interaction with time of SHC. Compared with neither counseling, diet and physical activity counseling, alone or combined, were significantly associated with additional improvements in biomarkers after SHG, for example, body mass index (men: 0.03-0.06 kg/m2, women: 0.10-0.15 kg/m2) and waist circumference (men: 0.16-0.29 cm, women: 0.43-0.47 cm) in both sexes and high-density lipoprotein cholesterol in men (0.13-0.29 mg/dL). Modest improvements in biomarkers were associated with diet and physical activity counseling, although effect sizes were small.
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Thoracic aortic aneurysm: How to counsel, when to refer.
Cikach, F, Desai, MY, Roselli, EE, Kalahasti, V
Cleveland Clinic journal of medicine. 2018;(6):481-492
Abstract
Thoracic aortic aneurysm (TAA) is usually clinically silent and progresses slowly until a tipping point is reached, after which the aortic diameter can expand more rapidly and the condition can potentially end in aortic dissection or rupture. Causes include bicuspid aortic valve and genetic syndromes (Marfan, Loeys-Dietz, and Ehlers-Danlos syndromes) and familial associations, but many cases are idiopathic. Clinicians should therefore be alert for clues on chest imaging, and consider screening in first-degree relatives of patients known to have aortic disease. Early referral to a cardiologist specializing in aortic disease is key.
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Effects of a Pre-surgery Supervised Exercise Training 1 Year After Bariatric Surgery: a Randomized Controlled Study.
Baillot, A, Vallée, CA, Mampuya, WM, Dionne, IJ, Comeau, E, Méziat-Burdin, A, Langlois, MF
Obesity surgery. 2018;(4):955-962
Abstract
BACKGROUND We have previously reported on the benefits of Pre-Surgical Exercise Training (PreSET) on physical fitness and social interactions in subjects awaiting bariatric surgery (BS). However, data are needed to know whether these benefits are maintained post-BS. OBJECTIVES The purpose of this paper was to evaluate the effect of PreSET on physical activity (PA) level, physical fitness, PA barriers, and quality of life (QoL) 1 year (1-Y) after BS. METHODS Of the 30 participants randomized into two groups (PreSET and usual care), 25 were included in the final analysis. One year after BS, time spent in different PA intensities and number of steps were assessed with an accelerometer. Before BS and until 1-Y after BS, physical fitness was assessed with symptom-limited cardiac exercise test, 6-min walk test (6MWT), and sit-to-stand, half-squat, and arm curl tests. QoL, PA barriers, and PA level were evaluated with questionnaires. RESULTS The number of steps (7460 vs 4287) and time spent in light (3.2 vs 2.2 h/day) and moderate (0.6 vs 0.3 h/day) PA were higher in the PreSET group 1-Y after BS. The changes in 6MWT heart cost (1.3 vs 0.6 m/beats/min), half-squat test (38.8 vs 10.3 s), and BMI (- 16.8 vs - 13.5 kg/m2) were significantly greater in the PreSET group compared to those in the usual care group. No other significant difference between groups was observed. CONCLUSION The addition of the PreSET to individual lifestyle counseling seems effective to improve PA level and submaximal physical fitness 1-Y after BS. Studies with larger cohorts are now required to confirm these results. The trial was registered at clinicaltrials.gov (NCT01452230).
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Inconsistent Weight Communication Among Prenatal Healthcare Providers and Patients: A Narrative Review.
Weeks, A, Liu, RH, Ferraro, ZM, Deonandan, R, Adamo, KB
Obstetrical & gynecological survey. 2018;(8):423-432
Abstract
IMPORTANCE Gestational weight gain (GWG) is an independent and modifiable factor for a healthy pregnancy. Gestational weight gain above or below the Institute of Medicine Guidelines has been shown to impact both maternal and fetal health (eg, gestational diabetes, hypertension, downstream obesity). Healthcare providers (HCPs) have the potential to be reliable sources of evidence-based weight information and advice during pregnancy. OBJECTIVE The aim of this study was to summarize the literature assessing GWG discussions between patients and their HCPs in a clinical setting to better understand the knowledge that is currently being exchanged. EVIDENCE ACQUISITION A literature review was conducted by searching Ovid Medline, CINAHL, and Embase databases. All relevant primary research articles in English that assessed GWG discussions were included, whereas intervention studies were excluded. RESULTS A total of 54 articles were included in this review. Although the overall prevalence and content of GWG counseling varied between studies, counseling was often infrequent and inaccurate. Healthcare providers tended to focus more on women experiencing obesity and excessive GWG, as opposed to the other body mass index categories or inadequate GWG. Women of higher socioeconomic status, older age, nulliparous, history of dieting, low physical activity, and those categorized as overweight/obese were more likely to receive GWG advice. Patients also reported receiving conflicting facts between different HCP disciplines. CONCLUSIONS The evidence regarding GWG counseling in prenatal care remains variable, with discrepancies between geographic regions, patient populations, and HCP disciplines. RELEVANCE Healthcare providers should counsel their pregnant patients on GWG with advice that is concordant with the Institute of Medicine Guidelines.
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Nutritional counseling with or without systematic use of oral nutritional supplements in head and neck cancer patients undergoing radiotherapy.
Cereda, E, Cappello, S, Colombo, S, Klersy, C, Imarisio, I, Turri, A, Caraccia, M, Borioli, V, Monaco, T, Benazzo, M, et al
Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology. 2018;(1):81-88
Abstract
BACKGROUND To evaluate the benefit of oral nutritional supplements (ONS) in addition to nutritional counseling in head and neck cancer (HNC) patients undergoing radiotherapy (RT). METHODS In a single-center, randomized, pragmatic, parallel-group controlled trial (ClinicalTrials.gov: NCT02055833; February 2014-August 2016), 159 newly diagnosed HNC patients suitable for to RT regardless of previous surgery and induction chemotherapy were randomly assigned to nutritional counseling in combination with ONS (N = 78) or without ONS (N = 81) from the start of RT and continuing for up to 3 months after its end. Primary endpoint was the change in body weight at the end of RT. Secondary endpoints included changes in protein-calorie intake, muscle strength, phase angle and quality of life and anti-cancer treatment tolerance. RESULTS In patients with the primary endpoint assessed (modified intention-to-treat population), counseling plus ONS (N = 67) resulted in smaller loss of body weight than nutritional counseling alone (N = 69; mean difference, 1.6 kg [95%CI, 0.5-2.7]; P = 0.006). Imputation of missing outcomes provided consistent findings. In the ONS-supplemented group, higher protein-calorie intake and improvement in quality of life over time were also observed (P < 0.001 for all). The use of ONS reduced the need for changes in scheduled anti-cancer treatments (i.e. for RT and/or systemic treatment dose reduction or complete suspension, HR=0.40 [95%CI, 0.18-0.91], P = 0.029). CONCLUSION In HNC patients undergoing RT or RT plus systemic treatment, and receiving nutritional counseling, the use of ONS resulted in better weight maintenance, increased protein-calorie intake, improved quality of life and was associated with better anti-cancer treatment tolerance.
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A randomized clinical trial of the effectiveness of a Web-based health behaviour change support system and group lifestyle counselling on body weight loss in overweight and obese subjects: 2-year outcomes.
Teeriniemi, AM, Salonurmi, T, Jokelainen, T, Vähänikkilä, H, Alahäivälä, T, Karppinen, P, Enwald, H, Huotari, ML, Laitinen, J, Oinas-Kukkonen, H, et al
Journal of internal medicine. 2018;(5):534-545
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BACKGROUND Weight loss can prevent and treat obesity-related diseases. However, lost weight is usually regained, returning to the initial or even higher levels in the long term. New counselling methods for maintaining lifestyle changes are urgently needed. OBJECTIVES An information and communication technology-based health behaviour change support system (HBCSS) that utilizes persuasive design and methods of cognitive behavioural therapy (CBT) was developed with the aim of helping individuals to maintain body weight. The purpose of this study was to assess whether CBT-based group counselling combined with HBCSS or HBCSS alone helps to maintain improved lifestyle changes needed for weight loss compared to self-help guidance or usual care. METHODS A randomized lifestyle intervention for overweight or obese persons (BMI 27-35 kg m-2 and age 20-60 years), recruited from the population registry in the city of Oulu, Finland, was conducted. This study comprised six randomly assigned study arms: CBT-based group counselling (eight sessions led by a nutritionist), self-help guidance-based group counselling (SHG; two sessions led by a nurse) and control, each with or without HCBSS, for 52 weeks. Subjects visited the study centre for anthropometric measurements, blood sample collection and to complete questionnaires at baseline, 12 and 24 months. The main outcome was weight change from baseline to 12 months and from baseline to 24 months. RESULTS Of the 1065 volunteers screened for the study, 532 subjects (51% men) met the inclusion criteria and were enrolled. The retention rate was 80% at 12 months and 70% at 24 months. CBT-based counselling with HBCSS produced the largest weight reduction without any significant weight gain during follow-up. The mean weight change in this arm was 4.1% [95% confidence interval (CI), -5.4 to -2.8, P < 0.001) at 12 months and 3.4% (95% CI, -4.8 to -2.0, P < 0.001) at 24 months. HBCSS even without any group counselling reduced the mean weight by 1.6% (95% CI, -2.9 to -0.3, P = 0.015) at 24 months. CONCLUSION The combination of CBT-based group counselling and HBCSS-based weight management is feasible for overweight or obese individuals. Moreover, HBCSS alone could be disseminated to the population at large as an effective means of treating obesity.